The present invention relates to the decontamination arts. It finds particular application in conjunction with sterilizing or disinfecting medical instruments and equipment and will be described with particular reference thereto. It should be appreciated, however, that the invention is also applicable to a wide variety of technologies in which at least two components or reagents are kept separate until time of use and then combined through dissolution in a common solvent.
Decontamination connotes the removal of hazardous or unwanted materials, such as bacteria, mold spores, other pathogenic life forms, radioactive dust, and the like. Disinfection connotes the absence of pathogenic life forms. Sterilization connotes the absence of all life forms, whether pathogenic or not.
Heretofore, medical equipment and instruments have often been sterilized in a steam autoclave. Autoclaves kill life forms with a combination of high temperature and pressure. However, steam autoclaves have several drawbacks. The high temperature pressure vessels tend to be bulky and heavy. The high temperature and pressure tends to curtail the useful life of endoscopes, rubber and plastic devices, lenses, and portions of devices made of polymeric materials and the like. Moreover, a typical autoclave sterilizing and cool down cycle is sufficiently long that multiple sets of the medical instruments are commonly required.
Instruments which cannot withstand the pressure or temperature of the oven autoclave are often sterilized with ethylene oxide gas, particularly in larger medical facilities or hospitals. However, the ethylene oxide sterilization technique also has several drawbacks. First, the ethylene oxide sterilization cycle tends to be even longer than the steam autoclave cycle. Another drawback is that ethylene oxide sterilization is sufficiently sophisticated that trained technicians are commonly required, making it unsuitable for physician and dental offices and for other smaller medical facilities. Moreover, some medical equipment can not be sterilized with ethylene oxide gas.
Liquid disinfection systems have also been utilized for equipment which could not withstand the high temperatures of steam sterilization. Commonly, a technician mixes a liquid disinfectant composition and manually immerses the items to be decontaminated. The high degree of manual labor introduces numerous uncontrolled and unreported variables into the process. There are quality assurance problems with the weakening of the disinfectant chemicals due to aging on the shelf, and technician errors in the mixing of sterilants, control of immersion times, rinsing of residue, exposure to the ambient atmosphere after the rinsing step, and the like.
U.S. Pat. No. 5,662,866 to Siegel, et al. discloses a two-compartment cup for powdered sterilant reagent components. An outer cup holds a first reagent while an inner cup, disposed within the outer cup, holds a second reagent. Peripheral walls of inner and outer cups are affixed together at their open ends at flanges. A permeable sheet is affixed to the inner cup portion flange for ventedly sealing both cups. The outer cup is closed at its base by a first detachable base and the inner cup similarly closed by a second detachable base. In use, the two bases are opened to allow mixing of the two reagents. The two-compartment cup ensures sterilization with a reproducible, pre-measured dose of reagents, while also facilitating handling and shipping of the reagents.
The present invention provides for a new and improved two compartment cup or packaging assembly which does not require a second removable base and which is ideal for storing powdered reagents which are retained separately until time of use and are released in solution when a solvent is passed through both compartments.